NextDent Denture 3D+
K-Number: K191497 · 2019-11-01
ApplicantVertex-Dental B.V.
Decision Date2019-11-01
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NextDent Denture 3D+ is a medical device manufactured by Vertex-Dental B.V.. It received FDA 510(k) clearance on 2019-11-01 under approval number K191497. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NextDent Denture 3D+?
NextDent Denture 3D+ is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Vertex-Dental B.V.. The 510(k) number is K191497.
When was NextDent Denture 3D+ approved by the FDA?
NextDent Denture 3D+ received FDA 510(k) clearance on 2019-11-01, under approval number K191497.
What company makes NextDent Denture 3D+?
NextDent Denture 3D+ is manufactured by Vertex-Dental B.V..
What is the FDA product code for NextDent Denture 3D+?
The FDA product code for NextDent Denture 3D+ is EBI.
Other Devices by Vertex-Dental B.V.
Related Devices (Code: EBI)
K161330Pour AcrylicDentsply Sirona
K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry
K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc.
K160498Dentivera Milling DiscDental Solutions, LLC
K153590AvaDent Denture Base MaterialGlobal Dental Science
K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.